FACT Standards for Immune Effector Cells

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The topic for this week’s @The Kinetix Group PACT Executive Briefing is “The FACT Standards for Immune Effector Cells.” These accrediting standards were developed by the Foundation for the Accreditation of Cellular Therapy (FACT), using a consensus of experts to promote quality medical and laboratory practice across the field of immune effector cell therapy. Immune Effector Cells are cells that have been modified to effect a specific immune response, with a therapeutic intent.

Therapies made from Immune Effector Cells include genetically modified Chimeric Antigen Receptor T-cells (CAR T-cells), CAR-NK cells, and dendritic cell vaccines. This broad designation includes therapies with widely diverse manufacturing methods, therapeutic constructs, clinical indications, and safety and toxicity profiles.

In the USA, cooperative clinical trial groups require institutions entering patients on Hematopoietic Cellular Therapy (HCT) trials to have FACT accreditation. Most insurance companies require HCT programs to at least disclose FACT accreditation status as part of the application for Center of Excellence designation. As CAR-T cell products have received approvals, manufacturers have required that these products be administered in a FACT-accredited clinical program.

The focus of Immune Effector Cell Standards is the clinical unit, the collection facility responsible for starting the cellular therapy product, the cell processing and/or manufacturing facilities, and the care delivery sites for administration. These standards are as complex as the cell therapies they support and require thoughtful attention to the details as manufacturers develop their market access strategies.

Source: The Foundation for the Accreditation of Cellular Therapy (2024). FACT Standards for Immune Effector Cells Second Edition – Version 2.0; Accessed from: https://www.factglobal.org/standards/immune-effector-standards/

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